---
title: "Second call for expression of interest in coordinated assessment of clinical investigations / performance studies"
description: "On November 10th, 2025, the EU Member States and the European Commission opened a new call for sponsors to join the pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 2017/746 (IVDR)."
url: https://qbdgroup.com/en/regulatory-updates/second-call-for-expression-of-interest-in-coordinated-assessment-of-clinical-investigations-performance-studies
type: "Regulatory update"
language: en
published: 2025-11-17
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Second call for expression of interest in coordinated assessment of clinical investigations / performance studies\", https://qbdgroup.com/en/regulatory-updates/second-call-for-expression-of-interest-in-coordinated-assessment-of-clinical-investigations-performance-studies"
---
# Second call for expression of interest in coordinated assessment of clinical investigations / performance studies
> On November 10th, 2025, the EU Member States and the European Commission opened a new call for sponsors to join the pilot coordinated assessment of clinical investigations under Regulation (EU) 2017/745 (MDR) and performance studies under Regulation (EU) 2017/746 (IVDR).

The first call was launched on February 6th, 2025, and closed June 30th, 2025, but was only open to sponsors of medical device clinical investigations.

## What's new in this call?

- The pilot is now open to **both medical device clinical investigations and IVD performance studies**.
- Interested sponsors must submit an expression of interest using the official form and email it to SANTE-CA-CIPS@ec.europa.eu by **30 April 2026**.
- The eligibility criteria are clarified: the study must be multinational (involving at least two participating Member States) and subject to authorisation under MDR Art 62(1) or IVDR Art 58(1-2).
- The Commission has published an updated list of participating Member States, along with practical and organisational details for sponsors.
- The pilot continues to support the development of the future mandatory EU coordinated assessment system, allowing sponsors early experience with harmonised processes

## What does this mean for you?

This renewed call is highly relevant for sponsors planning multinational clinical investigations or IVD performance studies requiring authorisation. Whether stand-alone or linked to a clinical trial of a medicinal product, participation in the pilot enables:

- reduced administrative burden,
- more transparent and predictable interactions with competent authorities,
- simplified document handling, and
- a more harmonised EU authorisation process.

If you would like to assess whether your study could benefit from inclusion in the pilot, our consultants are available to support you. [Please feel free to get in touch](https://qbdgroup.com/en/services/regulatory-affairs#contact).

[![CTA RA update](https://no-cache.hubspot.com/cta/default/7030766/interactive-184700193895.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLI8VMdlPCTT9bJHdYEXIBJi2YIHzFobbNZPx7bZnxY9s7A1k2j2bUTYAusSjWL0GF9Me8LTI3%2B%2BxlIOhgjUe5krrhc385asuV1bL6EoYAzWs5Mabi0Nt4U7VSuf0O0V5Mbzm14ESYb5gaE33K3oYR6lIWqoTHp%2Bub5KaXllPRvrJVOmAnNbdpeSUY90rHVxZXkMjbSZOL%2BiVESCkoEFl1sCEg%3D%3D&webInteractiveContentId=184700193895&portalId=7030766)
---
Source: https://qbdgroup.com/en/regulatory-updates/second-call-for-expression-of-interest-in-coordinated-assessment-of-clinical-investigations-performance-studies — © QbD Group. Quote freely with attribution and a link back.